| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2018-RN-00640-1 |
| Product Name/Description |
Drager Fabius Anaesthesia Machine - Fabius Tiro
Serial Numbers: ASKM-0203 and ASKM-0197
ARTG Number:104223
(Draeger Australia Pty Ltd - Anaesthesia system) |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
23/05/2018 |
| Responsible Entity |
|
| Reason/Issue |
Whilst conducting production quality checks, Dräger became aware of a device where it was possible to dose 100% Nitrous Oxide. Draeger anaesthesia machines are equipped with a mechanical Oxygen minimum dosage module (S-ORC). This safety feature prevents the user from inadvertently setting hypoxic gas mixtures (with less than 21% oxygen) at the fresh gas mixer when Nitrous Oxide is selected as one of the carrier gases.
In the event of a fault, the S-ORC module would not prevent setting a Nitrous Oxide flow that would result in a hypoxic mixture from being dosed to the patient. The device would deliver exactly the set gas composition, which can be read on the electronic fresh gas flow displays. A hypoxic gas mixture would be immediately visible on the basis of the Oxygen monitoring. In addition, visual & audible alarms would be generated if the inspiratory oxygen concentration (FiO2) low alarm limit is violated.
To date, Draeger have not received complaints relating to this issue. |
| Recall Action |
Product Defect Correction |
| Recall Action Instructions |
Investigations have determined that the root cause was a burr not being removed from an internal component of the S-ORC during the production process.
Draeger are advising that they are currently producing replacement motors for the potentially affected devices.
Draeger Service has ordered the replacement motors and on receipt of the part from Germany, will contact the Biomedical Engineering team to arrange the installation and testing of the replacement motor.
In the meantime, users may continue to use the installed devices. However, it is important to ensure that the instructions, notes and warnings in the relevant Instructions For Use are observed and that the alarms are not disabled on the corresponding Oxygen2 and Nitrous Oxide monitoring devices. Always set gas flows so that at least 21% oxygen is dosed. If the anaesthesia machine drops below the low alarm limit for Fi02 and generates an alarm, please check the settings and adjust them as required.
This action has been closed out on 25/09/2018 |
| Contact Information |
03 9244 7248 - Draeger Australia |